MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 ARTIFICIAL URINARY SPHINCTER; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC

Model Number	72400160
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Urethral Stenosis/Stricture (4501); Urinary Incontinence (4572)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) experienced recurring incontinence and the device stopped working.The suspected cause of the returning of incontinence and the device deficiency was reported to be the end of the devices service life.A surgical procedure was performed, during which the physician repaired a fossa stricture and removed only the cuff to avoid erosion, as postoperative catheterization was required.All other components left in place.No further patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72400024, serial number: n/a, batch/lot number: 544557011, model/catalog description: balloon fgs 61-70 cm, unique identifier (udi) #: (b)(4).Model number/catalog number: 72400098, serial number: n/a, batch/lot number: 544967017, model/catalog description: control pump fgs, unique identifier (udi) #: (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Urethral stricture, recurrent incontinence and the reported device allegation of mechanical issue are acknowledged within the directions for use (dfu) and are not related to off-label use or failure to follow instructions.A risk review was completed; tissue damage related symptoms, altered therapeutic response and non-functioning devices are defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The reported patient symptoms of urethral stricture and urinary incontinence are known risks associated with this device type and indicated as such in the instructions for use.Based on the information available, the conclusion code of known inherent risk of device was assigned to this investigation.

• Brand Name: AMS 800 ARTIFICIAL URINARY SPHINCTER
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25486696
• Report Number: 2124215-2026-31501
• Device Sequence Number: 18772036
• Product Code: EZY
• UDI-Device Identifier: 00878953000718
• UDI-Public: (01)00878953000718(17)130417(10)543680002
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/17/2013
• Device Model Number: 72400160
• Device Catalogue Number: 72400160
• Device Lot Number: 543680002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/12/2026
• Date Device Manufactured: 04/21/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male